FDA Considers Web to Study Safe PrescribingBy M.L. Baker
As lawsuits move through the courts about the role of pain-reliever Vioxx in heart attacks, the FDA is considering whether the Internet can be used to see if drugs are prescribed safely.
According to this week's Federal Register, the FDA is planning to study whether a class of migraine drugs known as triptans are being prescribed appropriately.
These drugs, which include sumatriptan (Imitrex), rizatriptan (Maxalt) and naratriptan (Amerge), have been prescribed to millions of Americans.
Though very effective at reducing pain, they are not supposed to be prescribed for patients with vascular disease because they could raise those patients' chances of having a heart attack or stroke.
By targeting people looking for information about headaches online, the FDA hopes to find out how often triptans are prescribed to patients outside of recommended safety guidelines.
The FDA wants to find out if Internet surveys are less expensive and more accurate than current methods.
These methods include surveys of subpopulations in health maintenance organizations and compiling complaints that are spontaneously reported to the agency.
Solicited people will be asked to complete a questionnaire online. This will collect information about their health, demographics, as well as how and how often they take triptans.
To check that the information supplied is accurate, the FDA will ask a subset of those surveyed for their medical records.
In response to concerns that the survey would not reflect the general population, the FDA replied that part of the purpose of the pilot study is to determine whether its results can be trusted.
However, with nearly 130 million Americans and two-thirds of the adults getting online regularly, the FDA suggested that Web surveys might be less expensive and more accurate than current methods.
According the FDA, recent Internet-based studies do not reflect major biases. Both the Online Glucosamine Trial and an online lupus case-control group were able to recruit appropriate populations.
Though the FDA acknowledged that the people surveyed would probably have, on average, higher socioeconomic status, and "the FDA does not intend to generalize the study findings to all migraine patients or estimate a prevalence or incidence of inappropriate prescribing."
Other comments expressed concerns that the survey could cause undue worries about triptans or could be biased to recruit patients who take triptans inappropriately.
The FDA denied this, saying that the survey would recruit people with chronic headaches, and ask patients to describe their medications and medical conditions; it would not seek out patients with heart conditions.